Sitagliptin SUN

Country: European Union

Language: Bulgarian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
27-10-2022
Summary of Product characteristics Summary of Product characteristics (SPC)
27-10-2022
Public Assessment Report Public Assessment Report (PAR)
17-01-2022

Active ingredient:

sitagliptin fumarate

Available from:

Sun Pharmaceutical Industries Europe B.V.

ATC code:

A10BH01

INN (International Name):

sitagliptin fumarate

Therapeutic group:

Лекарства, използвани при диабет

Therapeutic area:

Захарен диабет тип 2

Therapeutic indications:

For adult patients with type 2 diabetes mellitus, Sitagliptin SUN is indicated to improve glycaemic control:as monotherapy:- in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance. as dual oral therapy in combination with:- metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control. - a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance. - a peroxisome proliferator-activated receptor gamma (PPARγ) agonist (i. a thiazolidinedione) when use of a PPARγ agonist is appropriate and when diet and exercise plus the PPARγ agonist alone do not provide adequate glycaemic control. as triple oral therapy in combination with:- a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. - a PPARγ agonist and metformin when use of a PPARγ agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. Sitagliptin SUN is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.

Product summary:

Revision: 1

Authorization status:

упълномощен

Authorization date:

2021-12-09

Patient Information leaflet

                                40
Б. ЛИСТОВКА
41
ЛИСТОВКА: ИНФОРМАЦИЯ ЗА ПАЦИЕНТА
СИТАГЛИПТИН SUN 25 MG ФИЛМИРАНИ ТАБЛЕТКИ
СИТАГЛИПТИН SUN 50 MG ФИЛМИРАНИ ТАБЛЕТКИ
СИТАГЛИПТИН SUN 100 MG ФИЛМИРАНИ ТАБЛЕТКИ
ситаглиптин (sitagliptin)
ПРОЧЕТЕТЕ ВНИМАТЕЛНО ЦЯЛАТА ЛИСТОВКА,
ПРЕДИ ДА ЗАПОЧНЕТЕ ДА ПРИЕМАТЕ ТОВА
ЛЕКАРСТВО, ТЪЙ КАТО ТЯ СЪДЪРЖА ВАЖНА
ЗА ВАС ИНФОРМАЦИЯ.
-
Запазете тази листовка. Може да се
наложи да я прочетете отново.
-
Ако имате някакви допълнителни
въпроси, попитайте Вашия лекар,
фармацевт
или медицинска сестра.
-
Това лекарство е
предписано лично на Вас. Не го
преотстъпвайте на други хора. То
може да им навреди, независимо че
признаците на тяхното заболяване са
същите като
Вашите.
-
Ако получите някакви нежелани
лекарствени реакции, уведомете Вашия
лекар,
фармацевт или медицинска сестра. Това
включва и всички възможни нежелани
реакции, неописани в тази листовка.
Вижте точка 4.
КАКВО СЪДЪРЖА ТАЗИ ЛИСТОВКА
1.
Какво представлява Ситаглиптин SUN и за
какво се използва
2.
Какво трябва да знаете, преди да
приемете Ситаглиптин SUN
3.
Как да приемате Ситаглиптин SUN
4.
Възможни нежелани реакции
5.
Как да съхранявате Ситаглиптин SUN
6.
Съдържание на опаковката и
допъ
                                
                                Read the complete document

Summary of Product characteristics

                                1
ПРИЛОЖЕНИЕ I
КРАТКА ХАРАКТЕРИСТИКА НА ПРОДУКТА
2
1.
ИМЕ НА ЛЕКАРСТВЕНИЯ ПРОДУКТ
Ситаглиптин SUN 25 mg филмирани таблетки
Ситаглиптин SUN 50 mg филмирани таблетки
Ситаглиптин SUN 100 mg филмирани таблетки
2.
КАЧЕСТВЕН И КОЛИЧЕСТВЕН СЪСТАВ
Ситаглиптин SUN 25 mg
филмирани таблетки
Всяка филмирана таблетка съдържа
ситаглиптинов фумарат, еквивалентен
на 25 mg ситаглиптин
(sitagliptin).
Помощно(и) вещество(а) с известно
действие
Всяка филмирана таблетка съдържа 4 mg
хидрогенирано рициново масло.
Ситаглиптин SUN 50 mg филмирани таблетки
Всяка филмирана таблетка съдържа
ситаглиптинов фумарат, еквивалентен
на 50 mg ситаглиптин
(sitagliptin).
Помощно(и) вещество(а) с известно
действие
Всяка филмирана таблетка съдържа 8 mg
хидрогенирано рициново масло.
Ситаглиптин SUN 100 mg филмирани таблетки
Всяка филмирана таблетка съдържа
ситаглиптинов фумарат, еквивалентен
на 100 mg
ситаглиптин (sitagliptin).
Помощно(и) вещество(а) с известно
действие
Всяка филмирана таблетка съдържа 16 mg
хидрогенирано рициново масло.
За пълния списък на помощните
вещества вижте точка 6.1.
3.
ЛЕКАРСТВЕНА ФОРМА
Филмирана таблетка.
Ситаглиптин SUN 25 mg филмирани таблетки
Светлорозови на цвят, кр
                                
                                Read the complete document

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Active ingredient sitagliptin fumarate

sitagliptin fumarate

ATC code A10BH01

A10BH01

Marketed by Sun Pharmaceutical Industries Europe B.V.

Sun Pharmaceutical Industries Europe B.V.

INN (International Name) sitagliptin fumarate

sitagliptin fumarate

Documents in other languages

Patient Information leaflet Patient Information leaflet Spanish 27-10-2022
Summary of Product characteristics Summary of Product characteristics Spanish 27-10-2022
Public Assessment Report Public Assessment Report Spanish 17-01-2022
Patient Information leaflet Patient Information leaflet Czech 27-10-2022
Summary of Product characteristics Summary of Product characteristics Czech 27-10-2022
Public Assessment Report Public Assessment Report Czech 17-01-2022
Patient Information leaflet Patient Information leaflet Danish 27-10-2022
Summary of Product characteristics Summary of Product characteristics Danish 27-10-2022
Public Assessment Report Public Assessment Report Danish 17-01-2022
Patient Information leaflet Patient Information leaflet German 27-10-2022
Summary of Product characteristics Summary of Product characteristics German 27-10-2022
Public Assessment Report Public Assessment Report German 17-01-2022
Patient Information leaflet Patient Information leaflet Estonian 27-10-2022
Summary of Product characteristics Summary of Product characteristics Estonian 27-10-2022
Public Assessment Report Public Assessment Report Estonian 17-01-2022
Patient Information leaflet Patient Information leaflet Greek 27-10-2022
Summary of Product characteristics Summary of Product characteristics Greek 27-10-2022
Public Assessment Report Public Assessment Report Greek 17-01-2022
Patient Information leaflet Patient Information leaflet English 27-10-2022
Summary of Product characteristics Summary of Product characteristics English 27-10-2022
Public Assessment Report Public Assessment Report English 17-01-2022
Patient Information leaflet Patient Information leaflet French 27-10-2022
Summary of Product characteristics Summary of Product characteristics French 27-10-2022
Public Assessment Report Public Assessment Report French 17-01-2022
Patient Information leaflet Patient Information leaflet Italian 27-10-2022
Summary of Product characteristics Summary of Product characteristics Italian 27-10-2022
Public Assessment Report Public Assessment Report Italian 17-01-2022
Patient Information leaflet Patient Information leaflet Latvian 27-10-2022
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Public Assessment Report Public Assessment Report Latvian 17-01-2022
Patient Information leaflet Patient Information leaflet Lithuanian 27-10-2022
Summary of Product characteristics Summary of Product characteristics Lithuanian 27-10-2022
Public Assessment Report Public Assessment Report Lithuanian 17-01-2022
Patient Information leaflet Patient Information leaflet Hungarian 27-10-2022
Summary of Product characteristics Summary of Product characteristics Hungarian 27-10-2022
Public Assessment Report Public Assessment Report Hungarian 17-01-2022
Patient Information leaflet Patient Information leaflet Maltese 27-10-2022
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Public Assessment Report Public Assessment Report Maltese 17-01-2022
Patient Information leaflet Patient Information leaflet Dutch 27-10-2022
Summary of Product characteristics Summary of Product characteristics Dutch 27-10-2022
Public Assessment Report Public Assessment Report Dutch 17-01-2022
Patient Information leaflet Patient Information leaflet Polish 27-10-2022
Summary of Product characteristics Summary of Product characteristics Polish 27-10-2022
Public Assessment Report Public Assessment Report Polish 17-01-2022
Patient Information leaflet Patient Information leaflet Portuguese 27-10-2022
Summary of Product characteristics Summary of Product characteristics Portuguese 27-10-2022
Public Assessment Report Public Assessment Report Portuguese 17-01-2022
Patient Information leaflet Patient Information leaflet Romanian 27-10-2022
Summary of Product characteristics Summary of Product characteristics Romanian 27-10-2022
Public Assessment Report Public Assessment Report Romanian 17-01-2022
Patient Information leaflet Patient Information leaflet Slovak 27-10-2022
Summary of Product characteristics Summary of Product characteristics Slovak 27-10-2022
Public Assessment Report Public Assessment Report Slovak 17-01-2022
Patient Information leaflet Patient Information leaflet Slovenian 27-10-2022
Summary of Product characteristics Summary of Product characteristics Slovenian 27-10-2022
Public Assessment Report Public Assessment Report Slovenian 17-01-2022
Patient Information leaflet Patient Information leaflet Finnish 27-10-2022
Summary of Product characteristics Summary of Product characteristics Finnish 27-10-2022
Public Assessment Report Public Assessment Report Finnish 17-01-2022
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Summary of Product characteristics Summary of Product characteristics Swedish 27-10-2022
Public Assessment Report Public Assessment Report Swedish 17-01-2022
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Summary of Product characteristics Summary of Product characteristics Norwegian 27-10-2022
Patient Information leaflet Patient Information leaflet Icelandic 27-10-2022
Summary of Product characteristics Summary of Product characteristics Icelandic 27-10-2022
Patient Information leaflet Patient Information leaflet Croatian 27-10-2022
Summary of Product characteristics Summary of Product characteristics Croatian 27-10-2022
Public Assessment Report Public Assessment Report Croatian 17-01-2022

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